FDA 510(k) Applications Submitted by WIENER LABORATORIES S.A.I.C.

FDA 510(k) Number Submission Date Device Name Applicant
K024116 12/13/2002 WIENER LAB. BILIRUBINA DIRECT AA WIENER LABORATORIES S.A.I.C.
K010421 02/12/2001 WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 WIENER LABORATORIES S.A.I.C.
K021332 04/26/2002 WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA WIENER LABORATORIES S.A.I.C.
K021334 04/26/2002 WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 WIENER LABORATORIES S.A.I.C.
K011953 06/21/2001 WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA WIENER LABORATORIES S.A.I.C.
K012065 07/02/2001 WIENER LAB. CREATININA CINETICA AA WIENER LABORATORIES S.A.I.C.
K012260 07/18/2001 WIENER LAB. UREA UV CINETICA AA WIENER LABORATORIES S.A.I.C.
K012326 07/23/2001 WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 WIENER LABORATORIES S.A.I.C.
K012329 07/23/2001 WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 WIENER LABORATORIES S.A.I.C.
K022962 09/06/2002 WIENER LAB. BILIRRUBINA TOTAL AA WIENER LABORATORIES S.A.I.C.
K013095 09/17/2001 WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 WIENER LABORATORIES S.A.I.C.
K013097 09/17/2001 WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 WIENER LABORATORIES S.A.I.C.
K013101 09/17/2001 WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA WIENER LABORATORIES S.A.I.C.
K013102 09/17/2001 WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 WIENER LABORATORIES S.A.I.C.
K013145 09/20/2001 WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. WIENER LABORATORIES S.A.I.C.
K023549 10/22/2002 WIENER LAB AMILASA 405 AA LIQUIDA WIENER LABORATORIES S.A.I.C.
K023550 10/22/2002 WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA WIENER LABORATORIES S.A.I.C.
K023551 10/22/2002 WIENER LAB GOT (AST) UV AA LIQUIDA WIENER LABORATORIES S.A.I.C.
K013652 11/06/2001 WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 WIENER LABORATORIES S.A.I.C.
K023744 11/07/2002 WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 WIENER LABORATORIES S.A.I.C.
K023889 11/21/2002 WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 WIENER LABORATORIES S.A.I.C.
K023992 12/02/2002 WIENER LAB COLINESTERASA AA WIENER LABORATORIES S.A.I.C.
K013983 12/03/2001 WIENER LAB. ALP 405 WIENER LABORATORIES S.A.I.C.
K024305 12/24/2002 WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 WIENER LABORATORIES S.A.I.C.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact